Helus Pharma (NASDAQ: HELP) (Cboe CA: HELP) has announced the appointment of Michael Halstead as chief executive officer, effective immediately. The move comes as the clinical-stage company advances its lead candidate HLP003 through Phase 3 development and prepares for potential commercialization.
Halstead brings 25 years of biopharmaceutical leadership experience to the role, most recently serving as president of Intra-Cellular Therapies. During his tenure there, he oversaw the development and commercialization of CAPLYTA, a treatment for bipolar depression and major depressive disorder, supported pipeline expansion, and helped lead the company’s $14.6 billion acquisition by Johnson & Johnson in 2025. His experience in bringing a psychiatric drug to market is expected to be valuable as Helus Pharma navigates the late-stage clinical and regulatory landscape.
The appointment comes at a pivotal time for the company. Enrollment has been completed in the Phase 3 APPROACH trial, with topline data expected in Q4 2026. Additionally, enrollment is continuing in the EMBRACE pivotal study. Helus Pharma is also advancing HLP004, a proprietary novel serotonergic agonist (NSA) for generalized anxiety disorder, which is currently in Phase 2 development.
“We are thrilled to welcome Michael to Helus Pharma at this critical juncture,” said a company spokesperson. “His proven track record in psychiatric drug development and commercialization will be instrumental as we progress HLP003 and HLP004.”
Helus Pharma, the commercial operating name of Cybin Inc., focuses on developing proprietary NSAs – synthetic molecules designed to activate serotonin pathways believed to promote neuroplasticity. These investigational therapies aim to address the large unmet need for people suffering from depression, anxiety, and other mental health conditions. HLP003 is being developed as an adjunctive treatment for major depressive disorder and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration.
The company’s pipeline and recent leadership change underscore its commitment to advancing innovative treatments in mental health. With a shift toward potential commercialization, Halstead’s experience in launching CAPLYTA and navigating a major acquisition could prove crucial for Helus Pharma’s future growth.
For more information on the press release, visit https://nnw.fm/wCjAp. For company updates and to learn more about Helus Pharma, visit www.helus.com.
